ISO 10993-15:2000
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys

Standard No.

ISO 10993-15:2000

Release Date

2000

Published By

International Organization for Standardization (ISO)

Status

Be replaced

Replace By

ISO 10993-15:2000/Cor 1:2001

Latest

ISO 10993-15:2019

Scope

This part of ISO 10993 provides guidance on general requirements for the design of tests for identifying and quantifying degradation products from finished metallic medical devices or corresponding material samples finished as ready for clinical use. It is applicable only to those degradation products generated by chemical alteration of the finished metallic device in an in vitro accelerated degradation test. Because of the accelerated nature of these tests, the test results may not reflect the implant or material behavior in the body. The described chemical methodologies are a means to generate degradation products for further assessments. This part of ISO 10993 is not applicable to degradation products induced by applied mechanical stress. NOTE Mechanically induced degradation, such as wear, may be covered in the appropriate product-specific standard. Where product-group standards provide applicable product-specific methodologies for the identification and quantification of degradation products, those standards should be considered. Because of the wide range of metallic materials used in medical devices, no specific analytical techniques are identified for quantifying the degradation products. The identification of trace elements (< 10) contained in the specific metal or alloy is not addressed in this part of ISO 10993, nor are specific requirements for acceptable levels of degradation products provided in this part of ISO 10993. This part of ISO 10993 does not address the biological activity of the degradation products; see instead the applicable clauses of ISO 10993-1 and ISO 10993-17.

ISO 10993-15:2000 Referenced Document

• ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process*， 2018-08-01 Update
• ISO 3585 Borosilicate glass 3.3 - Properties

ISO 10993-15:2000 history

• 2019 ISO 10993-15:2019 Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys
• 2000 ISO 10993-15:2000/Cor 1:2001 Biologicalevaluation of medical devices - Part 15: Identificationand quantification of degradation products from metals and alloys
• 2000 ISO 10993-15:2000 Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys